Expert system for insulin pump therapy

ABSTRACT

An apparatus comprising a controller. The controller includes an input/output (I/O) module and a rule module. The I/O module is configured to present a question for a patient when communicatively coupled to a user interface and receive patient information in response to the question via the user interface. The rule module is configured to apply a rule to the patient information and generate a suggested insulin pump setting from application of the rule. Other devices, systems, and methods are disclosed.

RELATED APPLICATIONS

This application is a continuation of application Ser. No. 16/507,380filed Jul. 10, 2019, which in turn application is a continuation ofapplication Ser. No. 14/962,535 filed Dec. 8, 2015, now U.S. Pat. No.10,357,607 issued Jul. 23, 2019, which in turn is a continuation ofapplication Ser. No. 14/684,495 filed Apr. 13, 2015, now U.S. Pat. No.9,474,856 issued Oct. 25, 2016, which in turn is a continuation ofapplication Ser. No. 13/530,404 filed Jun. 22, 2012, now U.S. Pat. No.9,008,803 issued Apr. 14, 2015, which in turn is a continuation ofapplication Ser. No. 12/774,991 filed May 6, 2010, now U.S. Pat. No.8,219,222 issued Jul. 10, 2012, which in turn is a continuationapplication Ser. No. 11/753,420 filed May 24, 2007, now U.S. Pat. No.7,751,907 issued Jul. 6, 2010, each of which is hereby fullyincorporated herein by reference.

TECHNICAL FIELD

The field generally relates to patient insulin management devices and,in particular, but not by way of limitation, to systems, devices andmethods for managing insulin therapy.

BACKGROUND

People who suffer from diabetes require insulin to keep their bloodglucose level as close as possible to normal levels. It is essential forpeople with diabetes to manage their blood glucose level to within anormal range. Complications from diabetes can include heart disease(cardiovascular disease), blindness (retinopathy), nerve damage(neuropathy), and kidney damage (nephropathy). Insulin is a hormone thatreduces the level of blood glucose in the body. Normally, insulin isproduced by beta cells in the pancreas. In non-diabetic people, the betacells release insulin to satisfy two types of insulin needs. The firsttype is a low-level of background insulin that is released throughoutthe day. The second type is a quick release of a higher-level of insulinin response to eating. Insulin therapy replaces or supplements insulinproduced by the pancreas.

Conventional insulin therapy typically involves one or two injections aday. The low number of injections has the disadvantage of allowinglarger variations in a person's insulin levels. Some people withdiabetes manage their blood glucose level with multiple daily injections(MDI). MDI may involve more than three injections a day and four or moreblood glucose tests a day. MDI offers better control than conventionaltherapy. However, insulin injections are inconvenient and require adiabetic person to track the insulin doses, the amount of carbohydrateseaten, and their blood glucose levels among other information criticalto control.

It is important for a diabetic person to be treated with the properamount of insulin. As discussed previously, high blood sugar can lead toserious complications. Conversely, a person with low blood sugar candevelop hypoglycemia. Ideally, insulin therapy mimics the way the bodyworks. An insulin pump is one way to mimic the body's insulinproduction. An insulin pump can provide a background or basal infusionof insulin throughout the day and provide a quick release or bolus ofinsulin when carbohydrates are eaten. If a person develops high bloodsugar, a correction bolus can be delivered by the pump to correct it.While insulin pumps improve convenience and flexibility for a diabeticperson, they can be sophisticated devices. Some insulin pumps can bedifficult to program. Proper use of an insulin pump requires a user togo through a learning curve to properly treat their diabetes using theinsulin pump.

SUMMARY

This document discusses, among other things, devices and methods formanaging insulin therapy. A device example includes a controller. Thecontroller includes an input/output (I/O) module and a rule module. TheI/O module is configured to present a question for a patient whencommunicatively coupled to a user interface and receive patientinformation in response to the question via the user interface. The rulemodule is configured to apply a rule to the patient information andgenerate a suggested insulin pump setting from application of the rule.

A method example includes presenting a question for a diabetic patientusing a device, receiving patient information into the device inresponse to the question, applying a rule to the patient information,and generating a suggested insulin pump setting from application of therule.

This summary is intended to provide an overview of the subject matter ofthe present patent application. It is not intended to provide anexclusive or exhaustive explanation of the invention. The detaileddescription is included to provide further information about the subjectmatter of the present patent application.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B illustrate portions of a device that includes an insulinpump.

FIG. 2 is a block diagram of an example of portions of a device toprovide assistance in maintaining and adjusting a patient's insulin pumptherapy.

FIG. 3 shows a flow diagram of a method to provide assistance inmaintaining and adjusting a patient's insulin pump therapy.

FIG. 4 is a block diagram of another example of portions of a device toprovide assistance in maintaining and adjusting a patient's insulin pumptherapy.

FIG. 5 is a diagram of yet another example of portions of a device toprovide assistance in maintaining and adjusting a patient's insulin pumptherapy.

FIG. 6 is a block diagram of a further example of portions of a deviceto provide assistance in maintaining and adjusting a patient's insulinpump therapy.

DETAILED DESCRIPTION

The following detailed description includes references to theaccompanying drawings, which form a part of the detailed description.The drawings show, by way of illustration, specific embodiments in whichthe invention may be practiced. These embodiments, which are alsoreferred to herein as “examples,” are described in enough detail toenable those skilled in the art to practice the invention. Theembodiments may be combined, other embodiments may be utilized, orstructural, logical and electrical changes may be made without departingfrom the scope of the present invention. The following detaileddescription is, therefore, not to be taken in a limiting sense, and thescope of the present invention is defined by the appended claims andtheir equivalents.

In this document, the terms “a” or “an” are used, as is common in patentdocuments, to include one or more than one. In this document, the term“or” is used to refer to a nonexclusive or, such that “A or B” includes“A but not B,” “B but not A,” and “A and B,” unless otherwise indicated.Furthermore, all publications, patents, and patent documents referred toin this document are incorporated by reference herein in their entirety,as though individually incorporated by reference. In the event ofinconsistent usages between this document and those documents soincorporated by reference, the usage in the incorporated reference(s)should be considered supplementary to that of this document; forirreconcilable inconsistencies, the usage in this document controls.

FIGS. 1A and 1B illustrate portions of a device 100 that includes aninsulin pump. The device 100 includes a cassette or cartridge ofinsulin. The cartridge is connectable to infusion tubing 140 connectableto a patient such as by a Luer lock 145 or infusion set 142. The device100 includes a display 102 and a user interface that may include thedisplay 102 and include one or more keys 104. Because proper use of aninsulin pump requires a user to go through a learning curve to properlytreat their diabetes using the pump, it is desirable for a pump toprovide assistance to the user, whether the user is a diabetic patient,a caregiver, or a clinician. An expert system provides assistance orcoaching to the user to effectively treat their diabetes using theinsulin pump device.

FIG. 2 is a block diagram of an example of portions of a device 200 toprovide assistance in maintaining and adjusting a patient's insulin pumptherapy. The device 200 includes a controller 205. The controller 205can be implemented using hardware circuits, firmware, software or anycombination of hardware, firmware and software. Examples, include amicrocontroller, a logical state machine, and a processor such as amicroprocessor, application specific integrated circuit (ASIC), or othertype of processor. The controller 205 is configured to perform orexecute a function or functions. Such functions correspond to modules,which are software, hardware, firmware or any combination thereof.Multiple functions may be performed in one or more modules. In someexamples, software or firmware is provided on a computer readablemedium. The computer readable includes instructions therein, which whenprocessed (such as by the controller 205 for example) results in adevice performing the functions described herein. Examples of a computerreadable medium include a compact disc (CD), memory stick, or remotestorage accessible via a communication network such as the internet or acell phone network.

The controller 205 includes an input-output (I/O) module 210. The I/Omodule 210 presents a question for a patient when the I/O module 210 iscommunicatively coupled to a user interface. The user interface mayinclude one or more pushbuttons or a keypad. The user interface mayinclude a display to visually present instructions and/or the questionto the user. The user of the device 200 may be a clinician or a diabeticpatient. The display may include a touch-screen. The user interface mayinclude a speaker to present instructions and questions audibly. Aspeaker may be desirable when the user has difficulty in reading adisplay.

The I/O module 210 receives patient information in response to thequestion via the user interface. In some examples, the question andresponse is included in a series of questions and responses that arepart of a patient interview by the device 200. A patient interview maycover a broad range of information. In some examples, the patientinformation may include patient health information such as a patienthealth status or whether the patient has any other health-relatedconditions. The health information also may include whether informationconcerning any drugs or medications the patient may be taking. Somedrugs may cause a person to need more insulin, or the patient may betaking a drug to slow down the absorption of food.

The patient information may include patient lifestyle information. Thelifestyle information may include whether a patient tends to eat highglycemic index foods, drinks alcohol, smokes, eats a bedtime snack, ahealth status of the patient, whether the patient is typically understress, whether the patient tends to be active, and the amount time thepatient spends exercising, for example. The patient information mayinclude patient demographic information. The demographic information mayinclude a patient's weight, age, and gender for example.

In some examples, the patient information may be stored in a memory 220communicatively coupled to the controller 205. The information may bestored in response to the questions or may be pre-stored in the device200. The controller 205 includes a rule module 215. The rule module 215applies a rule to the patient information and generates a suggestedinsulin pump setting from application of the rule. In some embodiments,the rule includes a decision tree. A decision tree may be implementedwith a series of IF-Then logic statements. The controller 205 traversesthe decision tree using the patient information. In some embodiments,the rule module 215 may include a look-up table stored in the memory220. The look-up table may have entries that include one or more insulinpump settings. The table may include multiple dimensions to take intoaccount multiple factors, responses, or other information.

An example of an insulin pump setting is a basal rate. Basal rate refersto a type of twenty-four hour background infusion of insulin by aninsulin pump that mimics the continuous background release of insulinfrom a normal pancreas. It is the rate of insulin delivery the patientnormally needs independent of the consumption of meals. The basal rateis typically specified in insulin units per hour (u/hr). The patientinformation may include a total daily dose (TDD) of insulin, or the rulemodule may determine a TDD from patient information including the typeof diabetes of the patient and the patient's weight, age, and level offitness. The rule included in the rule module 215 may determine that theamount of daily basal insulin according to a percentage of TDD, such as40%, 50%, or 60% for example. The percentage applied by the rule may becustomized according to the preferences of a clinician. The TDD is thendivided by 24 to obtain an average hourly basal rate. For example, if apatient's TDD is determined to be 40 units of insulin, and 50% of theTDD is used for basal delivery, the rule module 215 determines that theaverage basal rate is 20 units/24 hours or 0.83 u/hr.

Many insulin pump users may use three or more different basal ratesduring the course of a day. Basal rates can be adjusted to changedelivery every few minutes (e.g., 20-30 minutes) by increments as smallas 0.05 u/hr to better track changes in demand, such as from an increasetypically needed before dawn or a decrease needed during long activeperiods. The device 200 provides assistance in determining one or morebasal rates for the patient. For example, the rule may be a look-uptable that includes one or more basal rates indexed by an activity levelof the patient. The rule determines a lower basal rate during anincreased activity level of the patient. In another example, the rulemay increase a basal rate during times when the patient takes a drugthat causes the patient to need more insulin. In yet another example,the rule may decrease a basal rate or a segment of a basal rate patternif the patient is taking a drug to delay the digestion of food. Anotherexample of an insulin pump setting is a correction factor. A correctionfactor refers to the amount in drop in blood sugar, or blood glucose,for one unit of insulin. It is measured in milligrams per deciliter(mg/dl) per unit in the U.S. and in millimoles (mmol) per unit in othercountries. An insulin pump may use the correction factor toautomatically determine a bolus amount required for a high reading or areduction in a meal bolus for a below-target reading. The insulin pumpmay also use the correction factor to calculate the amount ofcarbohydrates a patient should eat to bring low blood sugar up to atarget blood sugar level. An appropriate correction factor brings a highblood glucose reading down using an automatically determined correctionbolus without a risk of going low.

The rule module 215 may include a rule such as the “1800 rule” insetting the correction factor. For example, if a person's TDD is 40units of insulin, the correction factor would be 1800/40, or 45 mg/dlper unit. (The 1800 rule corresponds to a “100 rule” if mmol are used.)The rule module 215 may also take into account factors such as aperson's age, weight, and activity level when setting the correctionfactor. Other rules include the 1700 rule (94 rule if mmol) and the 1500rule (83 rule if mmol). For example, under the 1700 rule the correctionfactor would be 1700/40 or 42.5 mg/dl. A clinician may prefer one ruleover another based on experience including rules that are not based onTDD. The rule to determine the correction factor may be customizedaccording to the preferences of the clinician.

Another example of an insulin pump setting is a carbohydrate ratio. Acarbohydrate ratio refers to the amount of carbohydrates covered by aunit of insulin. It is sometimes referred to as a carbohydrate factor,or carb factor, and is typically specified as grams of carbohydrates perunit of insulin. An insulin pump device may use the carbohydrate ratioto automatically determine a carbohydrate insulin bolus amount requiredto match a number of carbohydrates ingested by the patient, or at leastto keep post-meal blood glucose within a range that is healthy for apatient. For example, the patient may plan to eat seventy grams ofcarbohydrates. If the carbohydrate ratio is ten grams of carbohydratesper unit of insulin, the insulin pump may determine that seven units ofinsulin are required to cover the carbohydrates.

The rule module 215 may include a formula such as the “500 rule” insetting the carbohydrate ratio. For example, if a person's TDD is 40units of insulin, the carbohydrate ratio would be 500/40 or about 13grams per unit of insulin. The rule module 215 may also take intoaccount factors such as a person's age, weight, and activity level whensetting the carbohydrate ratio. Other formulas include the 550 rule andthe 600 rule. For example, under the 600 rule the carbohydrate ratiowould be 600/40 or 15 grams per unit of insulin. As discussed above, thelarger the carbohydrate ratio, the smaller a carbohydrate bolus becomes.Because a clinician may prefer one rule over another based onexperience; including rules that are not based on TDD, the rule todetermine the correction factor may be customized according to thepreferences of the clinician.

According to some examples, the memory 220 may store parametersassociated with an insulin pump initial setup. The rule module 215applies a rule to match the insulin pump parameters to at least one ofpatient health information, patient lifestyle information, and patientdemographic information to generate a suggested insulin pump initialsetup. The rule module 215 may apply the rule to the patient informationto determine at least one of an initial correction factor, an initialcarbohydrate ratio, and one or more initial basal rate patterns orprofiles. For example, as part of the device interview a patient mayenter those periods when the patient regularly exercises into the device200. The rule may generate different basal rates before, during, orafter the exercise periods. In another example, the patient enter thefact that she is pregnant or trying to get pregnant into the device 200.The rule may suggest more aggressive correction bolus targets. In afurther example, based on the demographic data the rule may determinedifferent insulin pump initial setups for children, teens, adultfemales, adult males, and seniors. The demographic information wouldinitially setup parameters including basal rates, carbohydrate boluslimits, insulin pump feature lockouts and enables.

FIG. 3 shows a flow diagram of a method to provide assistance inmaintaining and adjusting a patient's insulin pump therapy. At block305, a question is presented for a diabetic patient using a device. Atblock 310, patient information is received into the device in responseto the question. At block 315, a rule is applied to the patientinformation. At block 320, a suggested insulin pump setting is generatedfrom application of the rule.

FIG. 4 is a block diagram of another example of portions of a device 400to provide assistance in maintaining and adjusting a patient's insulinpump therapy. The device 400 includes an insulin pump 425 or pumpmechanism to deliver insulin to a patient, such as a positivedisplacement pump for example. The device 400 also includes a controller405 communicatively coupled to a memory 420. The controller 405 includesan I/O module 410 and a rule module 415. The memory 420 may storeparameters associated with insulin pump therapy. The rule module 415applies a rule to generate a suggested insulin pump initial setup.

The device 400 includes a user interface 430 communicatively coupled tothe I/O module 410. In some examples, the user interface 430 includes adisplay and the I/O module 410 presents one or more suggested insulinpump settings to the user via the user interface 430. The I/O moduleadditionally presents a request to the user for confirmation of theinsulin pump setting. After a request is received, the setting orsettings are adopted or activated by the device 400, such as by movingthe settings from the memory 420 to operating registers for example.

FIG. 5 is a diagram of an example of a device 500 to provide assistancein maintaining and adjusting a patient's insulin pump therapy. Thedevice 500 includes a computing device 550. Examples of a computingdevice 550 include among other things a personal computer (PC), laptopcomputer, and personal data assistant (PDA). The computing device 550includes a controller 505. The controller 505 includes an I/O module 510and a rule module 515. The computing device 550 also includes a userinterface 555 that includes a display and may include at least one of akeyboard or keypad and a computer mouse. The computing device 550further includes a communication port 545 communicatively coupled to theI/O module 510. The device 500 communicates information with an insulinpump 570 via the communication port 545. In some examples, thecommunication port 545 is a wireless port and the device 500communicates with the insulin pump 570 using wireless signals, such as aradio frequency (RF) port or infrared (IR) port for example. In someexamples, the communication port 545 is a wired port (e.g., a serialport) and the device 500 communicates with the insulin pump using aremovable communication cable.

The rule module 515 applies a rule to generate at least one insulin pumpsetting. The I/O module 510 presents the setting to a user as asuggested insulin pump setting via the user interface 555. The I/Omodule 510 also presents a request for confirmation of the insulin pumpsetting. When the I/O module 510 receives a confirmation, such asthrough the user interface 555 for example, the I/O module 510communicates the insulin pump setting to the insulin pump 570 via thecommunication port 545.

As set forth previously, a rule may be customized. In some examples, thecontroller 505 includes a rule development module 560 to develop a rulevia edits received via the I/O module 510. The rule development module560 is a rule editor that edits existing rules in addition to generatingnew rules. In some examples, the rule development module 560 displays arepresentation 580 of the rule when the I/O module 510 iscommunicatively coupled to the user interface 555. The rule developmentmodule 560 converts a manipulation of the displayed representation 580via the user interface into the edit to the rule.

The rule development module 560 provides doctors or clinical experts theability to develop and generate a new rule (or rule set) or to modifyrules via the user interface 555. The computing device 550 includessoftware that provides a flexible framework to create or modify rulessuch as by updating a graphical decision tree or a look-up table forexample. The software may be included in a computer readable medium,such as a compact disc (CD) for example, or the software may bedownloaded to the computing device 550 from remote storage, such as froma server for example. The computing device 550 uses the communicationport 545 to communicate the rule or rule set to the insulin pump 570.

Once a rule is developed, the doctor or clinical expert could publish orotherwise share a rule or set of rules. In some embodiments, rule setscan be stored in remote storage, such as a server for example. Thecomputing device 550 may be connected to a communication network, suchas the internet or a cell phone network for example. A doctor orclinical expert may download a rule or rule set from the remote storageand either download the rule set directly from the computing device 550into the insulin pump device 570 or modify the rule or rule set beforedownloading the modified rule or rule set to the insulin pump device570.

Returning to FIG. 4, the controller 405 may include a rule developmentmodule. The user interface 430 receives edits to a rule or rule set. Theedits are entered into the device 400 manually by the user via the userinterface 430. For example, the user may step through the rule with theaid of a display included in the user interface 430. The user may thenalter the rule with a keypad included in the user interface 430. Forexample, the user may enter a new look up table entry using the key pad,or add another branch to a decision tree or edit a branch of thedecision tree. In certain examples, an entire new rule or rule set isentered manually into the device 400 via the user interface 430.

In some examples, the device 400 of FIG. 4 or the insulin pump device570 of FIG. 5 stores data to track effectiveness of a new rule ormodified rule. For example, the insulin pump device 570 may track thenumber of times the blood glucose level of the patient returned to atarget blood glucose level or to within a target range of levels afterapplication of the rule. The effectiveness may be displayed as apercentage or as X successes out of Y applications on either a displayof the insulin pump device 570 or uploaded and displayed on a separatedevice, such as the computing device 550 in FIG. 5 for example.

Returning to the device of FIG. 2, in some examples, the rule module 215assigns weights to corresponding table entries in a rule. For example, acertain type of exercise (e.g. higher intensity) may be weighted higherwhen determining whether to suggest a different basal rate for thepatient during the exercise (versus suggesting a food to eat beforeexercise of lower intensity). In some examples, the rule module 215 usesone or more fuzzy logic rules to determine the question for display andany recommended action. The fuzzy logic rules may be used to blend anyweighted questions, responses, or actions. In some examples, the rulemodule 215 uses a rule involving application of artificial intelligencemethods to determine the questions and the actions to be presented. Insome examples, the weighting used by the rule is customizable.

In some examples, the memory 220 stores a database of food options inassociation with a known amount of nutrient content. The rule module 215uses the patient health, lifestyle, and demographic information setforth above and generates a suggested database of food options. Forexample, if the patient lifestyle information indicates that the patienttends to eat high glycemic index foods, or the patient healthinformation indicates that the patient is pregnant, the suggested database may include mostly low glycemic foods. If the controller 205 isincluded in a computing device 550 of FIG. 5 or other type of device,that device communicates the suggested database to the insulin pumpdevice 570 where it is stored. If the controller 205 is included in aninsulin pump device as in FIG. 4, the controller 405 only displays thesuggested portion of the database to a user.

Without an expert system, a pump user may go through several iterationsof trial and error in finding appropriate insulin pump settings. In someexamples, the device 200 uses blood glucose information as feedback tobetter tune insulin pump settings. The rule module 215 applies the ruleto blood glucose information, such as blood glucose data taken using ablood glucose monitor (GM), to determine one or more insulin pumpsettings.

The I/O module 210 may present an action for the user to take. In someexamples, the action presented may be a prompt for the user to enterblood glucose data into the device, download blood glucose data into thedevice, or to begin a blood glucose measurement. For example, the actionpresented may be a prompt to measure blood glucose level from a fingerstick and to enter the data into the I/O module 210 through a userinterface. In some examples, the device 200 includes a communicationport communicatively coupled to the controller 205. The I/O module 210receives the blood glucose data via the communication port from a secondseparate device that includes a glucose monitor. In some examples, thecommunication port includes a wireless communication port. A separatedevice may obtain the blood glucose data during a test executed using aninsulin pump. In some examples, the device 200 includes an insulin pumpcommunicatively coupled to the controller 205.

In some examples, the device 200 includes a GM. FIG. 6 is a diagram ofanother example of a device 600 to provide assistance in maintaining andadjusting a patient's insulin pump therapy. The device 600 includes acontroller 605 communicatively coupled to a memory 620. The controller605 includes an I/O module 610 and a rule module 615. The device alsoincludes a GM 680 communicatively coupled to the controller 605. In someexamples, the device 600 also includes an insulin pump communicativelycoupled to the controller 605.

If the GM 680 is a continuous GM, no action is needed from the user toobtain blood glucose data. A continuous GM includes a blood glucosesensor to produce a blood glucose signal representative of a bloodglucose level of the patient. The blood glucose sensor may sense bloodglucose concentration from blood or interstitial fluid. The bloodglucose sensor circuit may include a sensor interface circuit to samplethe blood glucose signal and may provide additional signal processingsuch as filtering or amplification for example. The blood glucose sensorcircuit may provide sampled blood glucose data to the I/O module 610. Adescription of a blood glucose sensor circuit can be found in Steil etal., U.S. Pat. No. 6,558,351, filed Jun. 1, 2000. Returning to FIG. 2,the action presented by the I/O module 210 may include prompting theuser to begin a test or a series of tests in which blood glucose data ismonitored and received into the device 200 via the I/O module 210. Atest may be executed using an insulin pump. The rule module 215 appliesthe rule to at least one of the blood glucose data and the patientinformation to determine an insulin pump setting. In some examples, therule module 215 generates an insulin pump setting that includes a targetblood glucose level for the patient. The target blood glucose level maybe a range of blood glucose levels.

Because a patient's basal insulin needs may change over time, such aswith weight change or with a change in fitness level, basal rate testingmay be performed periodically to ensure that an appropriate basal rateis being delivered by an insulin pump. Based on blood glucose data(e.g., the blood glucose level of the patient is not at the target bloodglucose level), the rule module 215 may determine from the rule that abasal rate test should be run (by either the insulin pump included withthe device 200 or a separate device). The I/O module 210 may present(such as by display) a suggestion to the user to execute a basal ratetest. As a result of the basal rate test, the rule module 215 generatesone or more basal rate patterns or profiles. The I/O module 210 maydisplay a recommendation to change a programmable basal rate pattern ofthe insulin pump. Descriptions of devices and methods that perform abasal rate test are found in Blomquist et al., “Basal Rate Testing UsingFrequent Blood Glucose Input,” U.S. patent application Ser. No.11/685,617, filed Mar. 13, 2007, which is incorporated herein byreference.

If a carbohydrate ratio is too small, the insulin pump may determine acarbohydrate bolus that is too large for the carbohydrates consumed.This may cause a low blood glucose level within a few hours of thecarbohydrate bolus (e.g., the blood glucose level drops below 70 mg/dl).If a carbohydrate bolus is too large, the insulin pump may determine acarbohydrate bolus that is too small for the carbohydrates consumed.This may cause a high blood glucose level within a few hours of acarbohydrate bolus.

Based on the blood glucose data, the rule module 215 may determine thata recommendation to run a carbohydrate ratio test should be presented.As a result of the carbohydrate ratio test, the rule module 215 maygenerate a new carbohydrate ratio. The I/O module 210 may present arecommendation to change the carbohydrate ratio programmed in theinsulin pump. In some examples, the rule module 215 may generate acarbohydrate insulin bolus pattern or profile to be delivered by theinsulin pump. For example, the I/O module 210 may display a recommendedcarbohydrate bolus pattern that includes an extended carbohydrate bolusor a combination bolus. Descriptions of devices and methods that performa carbohydrate ratio test are found in Blomquist, “Carbohydrate RatioTesting Using Frequent Blood Glucose Input,” U.S. patent applicationSer. No. 11/679,712, filed Feb. 27, 2007, which is incorporated hereinby reference.

It is important for an insulin pump to use an effective correctionfactor. If a correction factor for a pump is set too high, the bloodglucose may not actually be dropping as much as estimated and could leadto high blood glucose levels. If the correction factor is set too low, acorrection bolus may provide too much insulin and result in a low bloodglucose level.

Based on the blood glucose data, the rule module 215 may apply the ruleto the blood glucose data and present a recommendation that the userinitiate a correction factor test. As a result of the correction factortest, the rule module 215 may generate a new a correction factor. TheI/O module 210 may present a recommendation to change the correctionfactor programmed in the insulin pump. In some examples, the rule module215 may generate an insulin correction bolus pattern or profile. Forexample, the I/O module 210 may display a recommended correction bolussuch as a pattern including different correction factors for differenttimes of the day for example. Descriptions of devices and methods thatperform a carbohydrate ratio test are found in Blomquist et al.,“Correction Factor Testing Using Frequent Blood Glucose Input,” U.S.patent application Ser. No. 11/626,653, filed Jan. 24, 2007, which isincorporated herein by reference. If the device 200 includes an insulinpump, the controller 205 may executes one of the tests described.

The examples set forth above involved the device 200 recommending anaction for the user to take based on the blood glucose data receivedinto the device. In some examples, the rule module 215 may use the bloodglucose data to first generate a question to be presented by the I/Omodule 210 before presenting an action. The rule module 215 generatesthe suggested insulin pump setting from application of the rule to theblood glucose data and patient information received in response to thequestion. For example, if the blood glucose data indicates blood glucoseis low, the rule may include a look up table having a question as towhether the patient had a high activity level. If the device 200receives a response through a user interface that the activity level washigh, the look up table may include a recommended action correspondingto a table entry for low blood glucose and high activity. The tableentry may include a recommended action that the patient eat before theactivity or lower a programmable basal rate of insulin before, during,or after the activity.

In some examples, the controller 205 determines a rate of change of ablood glucose level of the patient from the blood glucose data. As anillustrative example, the controller 205 may determine that the bloodglucose concentration level is increasing or decreasing at a rate of 2to 4 mg/dl/min (milligrams per deciliter per minute). The rule module215 may apply one or more rules to the rate of change of a blood glucoselevel to generate a suggested insulin pump setting. If the blood glucoselevel is high and increasing at a certain rate, the rule module 215 mayapply the rule to generate an insulin correction bolus pattern.

The action presented by the I/O module 210 may be a test or tests thatinclude a variety of steps. The tests may be included in the rule module215 and are designed to obtain data or other information that isanalyzed by the rule. The tests may occur over a series of days. Forexample, during the test the device 200 may instruct the insulin pumpuser to skip breakfast the first day, skip lunch the second day, andskip dinner the third day. The device 200 may display an action for theuser that includes taking blood glucose measurements at specified timesin the test, such as pre-meal, post-meal, and while fasting for example.The device 200 may ask the user to perform or not perform certainactivities (e.g., exercise) during the testing. The device may presentan action to the user to eat specific portions of food having specificnutritional content. As part of the test, the device 200 may ask theuser to input patient information into the device 200 (e.g., through theuser interface, or through a second separate device that communicateswith the device 200 via a communication port). The patient informationmay include health information, stress level information, or otherinformation pertinent to later test analysis.

After the testing, the device 200 presents one or more questions to theuser. The questions and responses from the user are part of a post-testpatient interview by the device 200. The information from the patientinterview and the blood glucose data are then analyzed. The rule module215 applies the rule to the responses during the interview, the bloodglucose data obtained as part of the test, and any other test data. Therule module 215 generates changes to insulin therapy parameters. In someexamples, the changes are presented to the user, and the user has theoption of accepting the changes.

If the device 200 includes an insulin pump, the changes are adopted bythe device 200. If the device is a computing device such as in FIG. 5,or a device that includes a GM that is separate from the insulin pump,the changes may be communicated to the insulin pump. According to someexamples the functions can be accomplished using multiple devices. Forexample, a first device may guide the patient through the test or tests.This device may include an insulin pump such as the device 400 in FIG.4. The patient interview and analysis may be done by a second devicesuch as the device 500 in FIG. 5.

As set forth previously, a rule or set of rules may be customized, suchas by a rule development module included in the controller 205 forexample. In some examples, all or substantially all aspects of the ruleare customizable, including the type of tests to run, the sequence oftests to run, the steps in the tests, and the criteria for makingchanges. An expert in the treatment of diabetes would customize therules to suit their standard of practice.

According to some embodiments, the device 200 may present changes otherthan insulin pump therapy parameters. In some examples, the rule module215 may generate a recommend change to a patient lifestyle, such as arecommendation to exercise more or to reduce smoking. The I/O module 210presents the recommend changes to the lifestyle of the patient. In someexamples, the rule module 215 may generate a recommend change to apatient diet, such as a recommendation to eat foods having a lowerglycemic index or to consume less alcohol.

It is to be understood that the above description is intended to beillustrative, and not restrictive. For example, the above-describedembodiments (and/or aspects thereof) may be used in combination witheach other. Many other embodiments will be apparent to those of skill inthe art upon reviewing the above description. The scope of the inventionshould, therefore, be determined with reference to the appended claims,along with the full scope of equivalents to which such claims areentitled. In the appended claims, the terms “including” and “in which”are used as the plain-English equivalents of the respective terms“comprising” and “wherein.” Also, in the following claims, the terms“including” and “comprising” are open-ended, that is, a system, device,article, or process that includes elements in addition to those listedafter such a term in a claim are still deemed to fall within the scopeof that claim. Moreover, in the following claims, the terms “first,”“second,” and “third,” etc. are used merely as labels, and are notintended to impose numerical requirements on their objects.

The Abstract of the Disclosure is provided to comply with 37 C.F.R. §0.1.72(b), requiring an abstract that will allow the reader to quicklyascertain the nature of the technical disclosure. It is submitted withthe understanding that it will not be used to interpret or limit thescope or meaning of the claims. In addition, in the foregoing DetailedDescription, it can be seen that various features are grouped togetherin a single embodiment for the purpose of streamlining the disclosure.This method of disclosure is not to be interpreted as reflecting anintention that the claimed embodiments require more features than areexpressly recited in each claim. Rather, as the following claimsreflect, inventive subject matter lies in less than all features of asingle disclosed embodiment. Thus the following claims are herebyincorporated into the Detailed Description, with each claim standing onits own.

1. (canceled)
 2. A method of providing diabetes therapy, comprising:prompting a patient to enter patient information including one or moreof patient demographic information, patient health information andpatient lifestyle information into a user interface of a user-wearableinfusion pump system; applying one or more stored rules to the patientinformation; generating one or more initial pump settings for an initialset up of a user-wearable infusion pump for the patient based on theapplication of the one or more stored rules to the patient information;causing the user-wearable infusion pump to deliver insulin to thepatient according to the one or more initial pump settings; receivingglucose level data of the user while insulin is being delivered to thepatient according to the one or more initial pump settings; andgenerating one or more modified pump settings that modify one or more ofthe initial pump settings based on the glucose level data.
 3. The methodof claim 2, further comprising automatically causing the user-wearableinfusion pump to deliver insulin to the patient according to the one ormore modified pump settings.
 4. The method of claim 2, furthercomprising presenting the one or more modified pump settings to thepatient on the user interface as one or more recommended modifications.5. The method of claim 2, wherein generating one or more initial pumpsetting includes generating one or more of a basal rate pattern, acorrection factor and a carbohydrate ratio.
 6. The method of claim 2,further comprising comparing the glucose level data to one or moretarget glucose levels, and wherein the modified pump settings aregenerated based on the comparison.
 7. The method of claim 2, whereinprompting the patient to enter patient information includes presentingone or more questions to the patient on the user interface.
 8. Themethod of claim 2, wherein patient demographic information includes oneor more of the patient's weight, age and gender.
 9. The method of claim2, wherein patient lifestyle information includes one or more of dietaryinformation and activity level information of the patient.
 10. Themethod of claim 2, wherein dietary information of the patient includes acarbohydrate ratio for the patient.
 11. The method of claim 2, whereinpatient health information includes one or more of a patient healthstatus, patient health-related condition, and patient medication. 12.The method of claim 2, further comprising monitoring glucose level datareceived while insulin is being delivered to the patient according tothe modified pump settings and generating further modifications to theone or more modified pump settings based on the glucose level data. 13.A user-wearable infusion pump system; a pump configured to deliverinsulin to a patient; a user interface; a memory; and a controller inelectrical communication with the pump, the memory and the userinterface, wherein the controller is configured to: prompt the patientto enter patient information including one or more of patientdemographic information, patient health information and patientlifestyle information through the user interface; apply one or morerules stored in the memory to the patient information; generate one ormore initial pump settings for an initial set up of the pump for thepatient based on the application of the one or more stored rules to thepatient information; cause the pump to deliver insulin to the patientaccording to the one or more initial pump settings; receive glucoselevel data of the user while insulin is being delivered to the patientaccording to the one or more initial pump settings; and generate one ormore modified pump settings that modify one or more of the initial pumpsettings based on the glucose level data.
 14. The system of claim 13,wherein the controller is configured to automatically cause theuser-wearable infusion pump to deliver insulin to the patient accordingto the one or more modified pump settings.
 15. The system of claim 13,wherein the controller or is configured to present the one or moremodified pump settings to the patient on the user interface as one ormore recommended modifications.
 16. The system of claim 13, whereingenerating one or more initial pump setting includes generating one ormore of a basal rate pattern, a correction factor and a carbohydrateratio.
 17. The system of claim 13, wherein the controller is configuredto compare the glucose level data to one or more target glucose levels,and wherein the modified pump settings are generated based on thecomparison.
 18. The system of claim 13, wherein prompting the patient toenter patient information includes presenting one or more questions tothe patient on the user interface.
 19. The system of claim 13, whereinpatient demographic information includes one or more of the patient'sweight, age and gender.
 20. The system of claim 13, wherein patientlifestyle information includes one or more of dietary information andactivity level information of the patient.
 21. The system of claim 20,wherein dietary information of the patient includes a carbohydrate ratiofor the patient.
 22. The system of claim 13, wherein patient healthinformation includes one or more of a patient health status, patienthealth-related condition, and patient medication.
 23. The system ofclaim 13, wherein the controller is configured to monitor glucose leveldata received while insulin is being delivered to the patient accordingto the modified pump settings and to generate further modifications tothe one or more modified pump settings based on the glucose level data.